May 23, 2008—With public comments in from about 55 sources, the U.S. Food and Drug Administration (FDA) is now proceeding to prepare a recommendation for an electronic pedigree (e-pedigree) system that pharmaceutical makers, distributors and retailers would required to use to identify products as they moved through the supply chain. The track-and-trace solution would be used to not only record which parties handled a drug during shipment, but also verify its authenticity and thwart counterfeiting. The FDA was accepting public comment until May 19, and now it will begin the process of analyzing those comments before making its recommendation as to how drugs would be tracked, what technology and what standards might be used, and who could help create those standards. A spokesperson for the FDA says the agency is still reviewing the responses and could not yet comment on the agency's next step.

In 2007, the U.S. Congress passed the Food and Drug Administration Amendment Act (FDAAA), mandating the FDA to evaluate potential e-pedigree systems and based on that evaluation, to make recommendation by January 2010 (see All Eyes on FDA for Drug E-pedigree). To help guide it in this endeavor, the FDA asked the public which technologies are the most appropriate for a pedigree system, what their strengths and limitations are, how interoperable they are, what standards are necessary and what is the development were of those standards.

Public responses came mostly from health-care industry associations, technology vendors and pharmaceutical distributors and manufacturers, the majority of which recommended RFID technology, with many recommending 2-D bar-coding as a backup up technology in the event an RFID tag failed, and urging the FDA to consider using GS1 standards for either technology. Several vendors of nanotechnology products recommended their own solutions for authentication, while several individuals also responded, stating that any pedigree system was going to be a burden for pharmacies and health-care providers.

While most of the responders agreed that non-line-of-sight technology—which thus far is provided only by RFID—was the most effective solution for track and trace as well as for authentication, there were concerns about its cost and accuracy and whether the RF waves would degrade or affect the quality of the pharmaceutical that is being tracked.

The California State Board of Pharmacy commented, "We are encouraged by the timely request for information and support expeditious action by the FDA in this vital standards-setting endeavor." Of the states that have independently been pursuing a pedigree system for drugs that enter their borders, California has made the most progress. The California pedigree law was first enacted in 2004, with an initial effective date of January 1, 2007, and then modified and extended in 2006 to Jan. 1, 2009. Recently, the board further extended the effective date for implementation of the pedigree requirements to Jan.1, 2011. The board noted in its statement to the FDA that both the FDA and California prefer—and assume the FDA's recommended system will utilize—RFID technology.

USER COMMENTS

Andrew Strauch

2008-05-30 11:56:01 AM

The RFID Tag Physical Security Hole
The general benefits of RFID for pharmaceutical e-pedigree applications are well stated in the FDA public comments. However, one major assumption must be addressed.
Assuming that typical RFID tags are less likely to be counterfeited or duplicated is extremely dangerous. As it stands, RFID systems track RFID tags – not the asset to which the tag is attached. Counterfeits can simply remove the tags without affecting the RFID function. The tags can then be placed on counterfeit items, or placed back in the empty carton. The reader will be none the wiser.
Robust tamper evidence is needed to ensure a unique relationship between the RFID tag and the actual pharmaceutical product. Without this, the pharmaceutical industry cannot be certain that e-pedigrees remain secure.
According to the U.S. Chamber of Commerce, the pharmaceutical industry loses $32 billion annually to counterfeiting. With that much revenue on the line, the pharmaceutical industry must stay at least one step ahead of counterfeiters. This means physical security on top of data security.
Andrew Strauch
MIKOH Corporation

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